Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Global Regulatory Affairs Director - Devices & Drug-Device

$238k - $374k

Dormont Manufacturing Co

Takeda is seeking an Executive Director for Global Regulatory Affairs in Boston, MA. This role will provide strategic leadership on regulatory affairs for medical devices and drug-device combination products, ensuring compliance and timely approvals. The ideal candidate must possess an advanced degree, over 20 years of experience in the industry, and a strong background in regulatory submissions. This position offers an attractive salary range of $238,000 - $374,000 and comprehensive benefits. #J-18808-Ljbffr Dormont Manufacturing Co

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Director - Devices & Drug-Device in Boston, MA vacancy
  • $238k - $374k

     ...boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will provide strategic leadership and development to global regulatory... 
    Suggested
    Temporary work
    Work at office
    Local area
    Remote work
    Worldwide

    JobRx, Inc.

    Boston, MA
    1 day ago
  • $238k - $374k

    JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years of industry experience...  ...expertise in regulatory submissions for medical devices and combination products. You will oversee a team to develop... 
    Suggested

    JobRx, Inc.

    Boston, MA
    1 day ago
  • A global health innovation company is seeking an Executive Director for Global Regulatory Affairs to lead strategic initiatives for medical devices and drug-device combination products. The role requires over 20 years of industry experience with significant expertise in... 
    Suggested
    Worldwide

    Takeda

    Boston, MA
    2 days ago
  • Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human...  ...opinion leader and foundational subject matter expert for global Human Factors regulation for devices/combination... 
    Suggested
    Night shift

    Scorpion Therapeutics

    Boston, MA
    3 days ago
  • $212k - $333.19k

     ...changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will...  ...driving prospective and proactive implementation. Globally influence and serve as a key opinion leader and resource... 
    Suggested
    Minimum wage
    Full time
    Temporary work
    Local area
    Worldwide
    Night shift

    Takeda

    Boston, MA
    3 days ago
  •  ...seeking a seasoned leader to define and execute the strategy for drug-device combination product development. The role involves managing...  ...industry. Successful candidates will demonstrate a strong regulatory background and proven experience in leading complex technical... 

    Scorpion Therapeutics

    Cambridge, MA
    2 days ago
  • $99k - $232k

     ...risk and compliance focus on maintaining regulatory compliance and managing risks for...  ...services to pharmaceutical and medical device clients Supervise, develop, and coach teams...  ...client relationships Specialization in global compliance program strategy and design... 

    PwC

    Boston, MA
    1 day ago
  • Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies for...  ...lifecycle management of Class II medical devices. Provide regulatory guidance during...  ...(RAC). Experience supporting global regulatory submissions (e.g., EU MDR,... 

    Medella Life

    Cambridge, MA
    1 day ago
  • $154.4k - $242.55k

     ...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team...  ...CMC requirements relevant to global drug development and post-market support.  Proven... 
    Minimum wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda Pharmaceutical Company Ltd

    Boston, MA
    5 days ago
  •  ...Executive Director, Global Regulatory Affairs Cmc Early Development Are you looking for a patient-focused company that will inspire...  ...functions (process development, analytical, formulation, drug substance/drug product, device/combination where applicable, quality, clinical,... 

    Takeda Pharmaceuticals

    Boston, MA
    4 days ago
  •  ...Job Description As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development...  ...(process development, analytical, formulation, drug substance/drug product, device/combination where applicable, quality, clinical,... 
    Temporary work
    Local area

    Initial Therapeutics, Inc.

    Boston, MA
    3 days ago
  • $270k - $330k

     ...Senior Director, Global Regulatory Affairs, Oncology Ipsen is a mid-sized global biopharmaceutical company...  ...incl PIP, scientific advice, orphan drug designation submissions. Advocate...  ...preferred): ~ Knowledge of medical device / drug device combination regulations... 
    Temporary work
    Local area
    Worldwide
    Flexible hours

    IPSEN

    Cambridge, MA
    5 days ago
  •  ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating... 

    Medella Life

    Cambridge, MA
    2 days ago
  •  ...Cardinal Health is looking for a Sr Regulatory Affairs Specialist to join their Medical Solutions Regulatory Affairs team. This remote position...  ...regulatory compliance across a diverse portfolio of medical devices, including new product development and change assessment.... 
    Remote work

    Cardinal Health

    Boston, MA
    4 days ago
  • $137k - $215.27k

     ...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team...  ...regulatory CMC requirements relevant to global drug development and post‑market support. Proven... 
    Minimum wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Initial Therapeutics, Inc.

    Boston, MA
    1 day ago
  • $188k - $258.5k

     ...development, and usability of drug delivery systems, with a strong...  ...human factors integration and regulatory readiness. Roles and...  ...partners. Facilitate alignment of device strategy across multiple programs...  ...development. Familiarity with global regulatory frameworks for medical... 
    Temporary work

    argenx SE

    Boston, MA
    1 day ago
  • $102.48k - $163.97k

     ..., ensuring their accuracy and regulatory compliance throughout the software...  ...pre- and post-market medical device software. Conducts detailed...  ...submission of documentation for global registrations to enable timely...  .../Vets and maintains a drug-free workplace. #J-18808-Ljbffr... 
    Full time
    Work at office
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Philips Iberica SAU

    Cambridge, MA
    3 days ago
  •  ...professionals for a part-time opportunity focused on providing feedback for an AI-powered platform that aids in medical device risk management and regulatory compliance. You will test new features, review documentation workflows, and influence product development based on... 
    Remote job
    Part time
    Flexible hours

    Wal-Mart

    Boston, MA
    4 days ago
  • $147k - $212k

     ...Job Title: GRA Device Lead (Associate Director) Location: Cambridge, MA/ Morristown, NJ About...  ...medicine? The race is on to speed up drug discovery and development to find...  ...teams accelerate progress.  The Global Regulatory Affairs (GRA) Device team is a globally... 
    Temporary work
    Local area
    Worldwide
    Flexible hours

    Zentiva Italia

    Cambridge, MA
    more than 2 months ago
  • $157.2k - $256.6k

     ...Associate Director, Global CMC Regulatory Strategy As an Associate Director you will...  ..., mentor CMC Regulatory Affairs (RA) staff, supporting cross...  ...licensure, and marketing of drugs and/or biologics. Lead and...  .... Experience with device regulatory requirements and... 
    Work at office
    Remote work
    Worldwide
    Relocation package
    3 days per week

    Regeneron

    Cambridge, MA
    5 days ago
  •  ...requires expertise in quality systems, complaint management, and regulatory compliance. The ideal candidate will possess a Bachelor's...  ...at least 5 years of experience in the pharmaceutical or medical device industry. This position offers an opportunity to impact product... 

    US WorldMeds

    Boston, MA
    5 days ago
  • $137k - $215.27k

    Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing regulatory... 

    Initial Therapeutics, Inc.

    Boston, MA
    17 hours ago
  • Makro Scientific is seeking an experienced professional to join their Global Regulatory Affairs team. The role involves planning, writing, and compiling regulatory reports such as DSURs and NDA annual reports, as well as contributing to product regulatory strategy documents... 

    Makro Scientific

    Cambridge, MA
    17 hours ago
  •  ...Description JOB TITLE: Executive Director, Global Regulatory Affairs DEPARTMENT: Regulatory Affairs...  ...regulatory expertise in oncology drug and biologic development, strong leadership...  ...diagnostics (CDx), biomarkers, devices, and combination products, ensuring... 

    AVEO Oncology

    Boston, MA
    4 days ago
  • $160.5k

     ...YouTube, LinkedIn and Tik Tok ( . Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is...  ...of the product. Demonstrates strong understanding of drug development and leadership behaviors consistent with level... 
    Temporary work
    Local area
    Worldwide

    AbbVie

    Boston, MA
    2 days ago
  • $196.7k - $353.4k

     ...is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader...  ...broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license... 
    Permanent employment
    Work at office
    Work from home

    Moderna

    Cambridge, MA
    1 day ago
  • $210k - $270k

     ...Nova Biomedical: One Global Brand. One Vision. Together under...  ...Oversees and leads the Regulatory Affairs function to ensure global regulatory...  ...2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 200...  ...over 100 countries to speed drug development and enhance... 
    Hourly pay
    Work at office
    Local area
    Flexible hours

    Nova Biomedical

    Watertown, MA
    1 day ago
  •  ...Proven Scientific Placement is seeking a Global Product Monitoring Vigilance Report...  ...maintaining best practices to meet customer and regulatory requirements. The ideal candidate will...  ...'s degree and experience in medical device reporting are required. #J-18808-Ljbffr... 

    Stratacuity: Proven Scientific Placement

    Boston, MA
    4 days ago
  •  ...AstraZeneca is seeking a Senior Regulatory Affairs Director in Boston, MA to lead global regulatory strategy for oncology programs. The role involves overseeing...  ...advanced degree in a relevant field, proven regulatory drug development experience, and demonstrated leadership... 
    Work at office
    Remote work

    Dormont Manufacturing Company

    Boston, MA
    18 hours ago
  • $154.4k - $242.55k

     ...Defines, develops and leads global strategies to maximize global regulatory success towards...  ...Accountabilities: The Associate Director will be responsible for...  ...Solid working knowledge of drug development process and...  ...concepts within regulatory affairs and implications across... 
    Minimum wage
    Temporary work
    Local area
    Remote work

    Dormont Manufacturing Co

    Boston, MA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory Affairs Director - Devices & Drug-Device. Be the first to apply!